Frequently Asked Questions About the
OPDIVO® (nivolumab) + YERVOY® (ipilimumab) Combination

Here are some frequently asked questions and answers that patients like you have had
about treatment with OPDIVO + YERVOY. Remember that this information is not a
substitute for talking with your healthcare professional. Your healthcare professional is the
best source of information about your condition.

HOW IS THE OPDIVO + YERVOY COMBINATION DIFFERENT FROM OTHER TREATMENTS?

The OPDIVO + YERVOY combination is not traditional chemotherapy. It is a powerful combination therapy that works with your immune system to fight cancer. The OPDIVO + YERVOY combination brings together 2 metastatic treatments that work together in complementary ways. It unites the breakthrough advancement of OPDIVO, a PD-1 (programmed death receptor-1) immunotherapy, with the established history of YERVOY. Chemotherapy, on the other hand, uses different drugs to kill or slow the growth of fast-growing cells, including cancer cells.

While doing so, OPDIVO and YERVOY could also affect non-tumor cells. Because of the way the OPDIVO + YERVOY combination works, it may cause your immune system to attack normal organs and tissues in your body and can affect the way they work. These problems can sometimes become serious or life-threatening and can lead to death. These problems may happen anytime during treatment or even after your treatment ends.


WHY SHOULD MY DOCTOR AND I CONSIDER THE OPDIVO + YERVOY COMBINATION?

Deciding on how you will fight metastatic melanoma is one of the most important decisions you and your oncologist will make. OPDIVO + YERVOY received approval from the FDA because of the percentage of patients with metastatic melanoma whose tumors shrank or disappeared during the clinical trial compared to those who received YERVOY alone. For more information, see Clinical Trial Results.

The OPDIVO + YERVOY combination reduced the risk of cancer spreading, growing, or getting worse by 58% compared with YERVOY alone. Half of the patients on OPDIVO + YERVOY were alive at 11.5 months without their cancer spreading, growing or getting worse, compared with 2.9 months for patients on YERVOY alone. The OPDIVO + YERVOY combination will not work for every patient. Individual results may vary. So talk to your oncologist to see if the combination is right for you.


HOW MANY PEOPLE PARTICIPATED IN THIS CLINICAL TRIAL?

The clinical trial included 945 adult patients with unresectable or metastatic melanoma who were previously untreated. Patients were treated with either the combination of OPDIVO + YERVOY, OPDIVO alone, or YERVOY alone.


CAN I BE PRESCRIBED THE OPDIVO + YERVOY COMBINATION REGARDLESS OF BRAF  STATUS?

Yes. The OPDIVO + YERVOY combination was studied in both BRAF negative (normal BRAF gene) and BRAF positive (abnormal BRAF gene) patients, and results were seen in both patient types.


WHERE CAN I GO TO GET MY OPDIVO + YERVOY TREATMENTS?

You and your doctor should discuss the best place to get your infusions, whether it’s your doctor’s office, an infusion center, or a local hospital.


HOW DO I KNOW IF I’M RESPONDING TO THE OPDIVO + YERVOY COMBINATION?

While undergoing treatment with the OPDIVO + YERVOY combination, your doctor will likely order periodic scans to evaluate whether there are any changes in the size of your tumors.


WHAT SHOULD I KNOW ABOUT POTENTIAL SIDE EFFECTS?

Some of the side effects of the OPDIVO + YERVOY combination may be life-threatening and may need your doctor’s immediate attention. Be sure to tell your doctor about all side effects as soon as possible, including any changes in how you are feeling, so he or she can help address them right away. OPDIVO can cause severe infusion reactions. Tell your doctor or nurse right away if you get these symptoms during an infusion of OPDIVO: chills or shaking; itching or rash; flushing; difficulty breathing; dizziness; fever; feeling like passing out.

What are the most common side effects of OPDIVO when used in combination
with YERVOY?

The most common side effects of OPDIVO, when used in combination with YERVOY, include: feeling tired; rash; diarrhea; nausea; fever; pain in muscles, bones, and joints; itching; abdominal pain; vomiting; cough; decreased appetite; and shortness of breath. The most common side effects of YERVOY include: feeling tired; diarrhea; nausea; itching; rash; vomiting; headache; weight loss; fever; decreased appetite; and difficulty falling or staying asleep.

What are the serious side effects of OPDIVO when used in combination with YERVOY?

OPDIVO can cause problems that can sometimes become serious or life-threatening and can lead to death. Serious side effects may include:

  • lung problems (pneumonitis)
  • intestinal problems (colitis) that can lead to tears or holes in your intestine
  • liver problems (hepatitis)
  • hormone gland problems (especially the thyroid, pituitary, adrenal glands, and pancreas )
  • kidney problems, including nephritis and kidney failure
  • skin problems
  • inflammation of the brain (encephalitis)
  • problems in other organs
  • severe infusion reactions

Additional serious side effects observed during a separate study of YERVOY alone include:

  • nerve problems that can lead to paralysis
  • eye problems

WHAT SHOULD I TELL MY
HEALTHCARE PROVIDER?

Before you receive the OPDIVO + YERVOY combination, tell your healthcare
provider if you:

  • Have immune system problems such as Crohn’s disease, ulcerative colitis, lupus, or sarcoidosis
  • Have had an organ transplant
  • Have lung or breathing problems
  • Have any other medical conditions
  • Are pregnant or plan to become pregnant
    • - OPDIVO and YERVOY can harm your unborn baby
    • - Females who are able to become pregnant should use an effective method of birth control during and for at least 5 months after the last dose of OPDIVO. Talk to your healthcare provider about birth control methods that you can use during this time.
    • - Tell your healthcare provider right away if you become pregnant or think you are pregnant during treatment. You or your healthcare provider should contact Bristol-Myers Squibb at 1-800-721-5072 as soon as you become aware of the pregnancy.
    • - Pregnancy Safety Surveillance Study: Females who become pregnant during treatment with YERVOY are encouraged to enroll in a Pregnancy Safety Surveillance Study. The purpose of this study is to collect information about the health of you and your baby. You or your healthcare provider can enroll in the Pregnancy Safety Surveillance Study by calling 1-844-593-7869.
  • Are breastfeeding or plan to breastfeed
    • - It is not known if either treatment passes into your breast milk
    • - Do not breastfeed during treatment and for 3 months after the last dose of YERVOY

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.


WHO CAN I TALK TO IF I NEED HELP OR HAVE QUESTIONS ABOUT OPDIVO + YERVOY?

Talk with your healthcare professional first if you have questions about this treatment option. You can also call a Care Navigator at 1-855-673-4861, 8 AM to 8 PM ET, Monday-Friday for general questions about the OPDIVO + YERVOY combination not specific to your health.


It can be helpful to review a list of questions you may want to ask
your doctor. Download Questions to Ask Your Doctor to help
answer your questions about whether OPDIVO + YERVOY may be
right for you.

See Clinical Trial Results

See how OPDIVO + YERVOY
performed in a clinical trial in patients.

See the Results

OPDIVO®  with You Program

Complimentary support, tools, and educational resources
for anyone considering or currently taking OPDIVO + YERVOY.
Call 1-855-OPDIVO-1 or click to
learn more.

Sign Up Now

Talking With Your Doctor Is Key

Review a list of questions with your
oncologist about whether OPDIVO + YERVOY is right for you.

Talk to Your Doctor

SELECT IMPORTANT FACTS ABOUT OPDIVO AND YERVOY

OPDIVO is a medicine that may treat your melanoma by working with your immune system. OPDIVO can cause your immune system to attack normal organs and tissues in many areas of your body and can affect the way they work. These problems can sometimes become serious or life-threatening and can lead to death. These problems may happen anytime during treatment or even after your treatment has ended. Some of these problems may happen more often when OPDIVO is used in combination with YERVOY.

YERVOY can cause serious side effects in many parts of your body which can lead to death. These problems may happen anytime during treatment with YERVOY or after you have completed treatment.

Important Facts About
OPDIVO® (nivolumab) and OPDIVO + YERVOY® (ipilimumab)

This is a summary of important information that you need to know about OPDIVO and OPDIVO + YERVOY. Your healthcare team can work with you to help answer any questions you may have about these medications. Keep this information in a safe place so you can refer to it before and during your treatment.

Look out for the following icons as you read:

  • Talk to your
    healthcare team
  • Call a healthcare
    provider right away
  • Helpful information
    to remember

What are OPDIVO and OPDIVO + YERVOY?

OPDIVO is a prescription medicine used to treat people who have a type of skin cancer called melanoma, and who:

Have melanoma that has spread or cannot be removed by surgery (advanced melanoma).

OPDIVO can be used alone or in combination with YERVOY (OPDIVO + YERVOY).

OPDIVO is approved for both BRAF+ and BRAF- patients. OPDIVO was approved for BRAF+ metastatic melanoma patients based on the amount of time patients lived without their tumors worsening. There is ongoing evaluation of clinical benefit of OPDIVO for this use.

OPDIVO + YERVOY was approved based on the amount of time patients lived without their tumors worsening. There is ongoing evaluation of clinical benefit of OPDIVO + YERVOY for this use.

It is not known if OPDIVO is safe and effective in children younger than 18 years of age.


What are the serious side effects?

A serious side effect is a side effect that can sometimes become life-threatening and can lead to death. They may happen anytime during treatment or even after your treatment has ended.

OPDIVO is a medicine that may treat certain cancers by working with your immune system. OPDIVO can cause your immune system to attack normal organs and tissues in any area of your body and can affect the way they work. Some of these problems may happen more often when OPDIVO is used in combination with YERVOY.

YERVOY can also cause serious side effects in many parts of your body which can lead to death. These problems may happen anytime during treatment with YERVOY or after you have completed treatment.

Get medical help immediately if you develop any of these symptoms or they get worse. It may keep these problems from becoming more serious. Your healthcare team will check you for side effects during treatment, and may treat you with corticosteroid or hormone replacement medicines. If you have a serious side effect, your healthcare team may need to delay or completely stop your treatment.

What are the serious side effects of OPDIVO and OPDIVO + YERVOY?

Lung problems (pneumonitis) — Things to look out for may include:

  • new or worsening cough
  • chest pain
  • shortness of breath

Intestinal problems (colitis) that can lead to tears or holes in your intestine — Things to look out for may include:

  • diarrhea (loose stools) or more
    bowel movements than usual
  • blood in your stools or dark,
    tarry, sticky stools
  • severe stomach area (abdomen)
    pain or tenderness

Liver problems (hepatitis) — Things to look out for may include:

  • yellowing of your skin or
    the whites of your eyes
  • severe nausea or vomiting
     
  • pain on the right side of your
    stomach area (abdomen)
  • drowsiness
  • dark urine (tea colored)
  • bleeding or bruising more easily
    than normal
  • feeling less hungry than usual
  • decreased energy

Hormone gland problems (especially the thyroid, pituitary, adrenal glands, and pancreas) — Things to look out for may include:

  • headaches that will not go away
    or unusual headaches
  • extreme tiredness
  • weight gain or weight loss
  • dizziness or fainting
  • changes in mood or behavior,
    such as decreased sex drive,
    irritability, or forgetfulness
  • hair loss

  • feeling cold
  • constipation
  • voice gets deeper
  • excessive thirst or lots of urine

Kidney problems, including nephritis and kidney failure — Things to look out for may include:

  • decrease in the amount of urine
  • blood in your urine
  • swelling in your ankles

  • loss of appetite

Skin problems — Things to look out for may include:

  • rash
  • itching
  • skin blistering
  • ulcers in the mouth or other
    mucous membranes

Inflammation of the brain (encephalitis) — Things to look out for may include:

  • headache
  • fever
  • tiredness or weakness
  • confusion
  • memory problems
  • sleepiness
  • seeing or hearing things that are not really there (hallucinations)
  • seizures
  • stiff neck

Problems in other organs — Things to look out for may include:

  • changes in eyesight

  • severe or persistent
    muscle or joint pains
  • severe muscle weakness
  • chest pain

Additional serious side effects observed during a separate study of YERVOY alone include:

Nerve problems that can lead to paralysis — Things to look out for may include:

  • unusual weakness of legs, arms, or face
  • numbness or tingling in hands or feet

Eye problems — Things to look out for may include:

  • blurry vision, double vision, or other vision problems
  • eye pain or redness

OPDIVO can cause serious side effects, including:

Severe infusion reactions — Things to look out for may include:

  • chills or shaking
  • itching or rash
  • flushing
  • difficulty breathing
  • dizziness

  • fever
  • feeling like passing out

Talk to your healthcare team right away if you get any of the symptoms of a severe infusion reaction during or after an infusion of OPDIVO.


What should I discuss with my healthcare team about pregnancy and nursing before starting treatment?

Tell your healthcare team if you are pregnant or plan to become pregnant. OPDIVO and YERVOY can harm your unborn baby. Females who are able to become pregnant should use an effective method of birth control during and for at least 5 months after the last dose of OPDIVO.

Talk to your healthcare team about birth control methods that you can use during this time. Tell your healthcare team right away if you become pregnant or think you are pregnant during treatment. You or your healthcare team should contact Bristol-Myers Squibb at as soon as you become aware of the pregnancy.

Enrolling in a Pregnancy Safety Surveillance Study is encouraged for females who become pregnant during treatment with YERVOY. The purpose of this study is to collect information about your health and the health of your baby. You or your healthcare provider can enroll in the Pregnancy Safety Surveillance Study by calling .

Tell your healthcare team if you are breastfeeding or plan to breastfeed. It is not known if either treatment passes into your breast milk. Do not breastfeed during treatment and for 3 months after the last dose of YERVOY.


What should I discuss with my healthcare team before starting treatment?

Talk to your healthcare team about all of your health problems or concerns, including if you:

  • have immune system
    problems such as autoimmune disease, Crohn’s disease, ulcerative colitis, lupus, or sarcoidosis
  • have had an organ transplant
  • have lung or breathing problems

  • have liver problems
  • have any other medical conditions

Talk to your healthcare team about all of the medicines you are taking, including:

  • prescription medicines
  • over‑the‑counter medicines
  • vitamins
  • herbal supplements

What are the most common side effects?

The most common side effects of OPDIVO when used alone include:

  • feeling tired
  • rash
  • pain in muscles, bones,
    and joints
  • itchy skin
  • diarrhea
  • nausea
  • weakness
  • cough
  • shortness of breath
  • constipation
  • decreased appetite
  • back pain
  • upper respiratory tract infection
  • fever
  • headache
  • abdominal pain

The most common side effects of OPDIVO when used in combination with YERVOY include:

  • feeling tired
  • rash
  • diarrhea
  • nausea
  • fever
  • pain in muscles, bones, and joints
  • itching
  • abdominal pain
  • vomiting
  • cough
  • decreased appetite
  • shortness of breath

     

The most common side effects of YERVOY include:

  • feeling tired
  • diarrhea
  • nausea
  • itching
  • rash
  • vomiting
  • headache
  • weight loss
  • fever
  • decreased appetite
  • difficulty falling or staying asleep

These are not all of the possible side effects. Talk to your healthcare team for more information. Call your doctor for medical advice about side effects. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call .

OPDIVO (10 mg/mL) and YERVOY (5 mg/mL) are injections for intravenous (IV) use.


For more information, please see U.S. Full Prescribing Information, including Boxed WARNING regarding immune-mediated side effects, and Medication Guide for YERVOY.

Please see U.S. Full Prescribing Information and Medication Guide for OPDIVO.

Talk to your healthcare team for more information about these medications.